Assessing Parenteral Antibiotics Versus Single-time Intra-operative Intra-dermal Antibiotic Administration for Prevention of SSI

The Grant Medical College & Sir J.J. Group of Hospitals

Overview

The purpose of the study is to study the incidence of surgical site infection when patients are given local versus parenteral antibiotics

Patients undergoing above 18 years of age, giving consent and undergoing open or laparoscopic elective, CDC class I \& II surgeries will be recruited. Cases will be randomised into two cohorts viz: parenteral antibiotic (Group A) vs single-time intra-operative intra-dermal antibiotic administration group (Group B). In operation theatre, after induction of anaesthesia, Group A will receive parenteral ceftriaxone (15-20mg/kg) whereas Group B will receive single-time intra-operative intra-dermal ceftriaxone (15-20mg/kg diluted in 10 ml normal saline). Post-operatively, incision site will be covered with occlusive dressing. First check-dressing will be done after 48 hours as per the existing institutional practices. After that surgical site will be inspected daily for wound infection. Patients with healthy wound will be discharged at the discretion of the treating surgeon and will be asked to follow up in General Surgery OPD weekly for one month. Cases who developed an SSI will have samples collected from the afflicted area for bacterial culture and antibiotic susceptibility testing. On development of SSI, the treating clinical team will commence antibiotic therapy as per their protocols.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Surgical Wound Infection Surgical Site Infection

Interventions

Ceftriaxone SodiumDRUG

Intravenous vs local action

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients above the age of 18 years * Patients undergoing open and laparoscopic elective, CDC class I \& II surgeries Exclusion Criteria: * Patients exhibiting hypersensitivity reaction to ceftriaxone * Patients who are immunocompromised (retroviral disease and corticosteroid use) * Patients not consenting to be a part of this study * Pregnancy * Febrile illness or leucocytosis at the time of surgery * Planned for staged/multiple interventions during the hospital stay (endoscopies, image-guided biopsies etc) * Patients with a possible septic focus distant from the surgical site such as diabetic foot ulcers.

Locations (1)

Grant Government Medical College and Sir JJ Hospital

Mumbai, Maharashtra, India

Outcomes

Primary Outcomes

Incidence of Surgical site infection

Infection occurs within 30 days after the operation and infection involves only skin or subcutaneous tissue of the incision and at least one of the following: 1. Purulent drainage, with or without laboratory confirmation, from the superficial incision. 2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision. 3. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless the incision is culture-negative. 4. Diagnosis of superficial incisional SSI by the surgeon or attending physician

Time frame: 1 month

Organism isolated from wound

Microorganism grown on wound swab - Nominal data

Time frame: 1 month

Secondary Outcomes

Total duration of hospital stay

Number of days of stay in the hospital - Ratio data (Numerical)

Time frame: 1 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.